What does 21 CFR Part 11 regulate in CBM T6 electronic records and signatures?

• A. Archive physical records only.
• B. System validation, audit trails, access controls, and data integrity controls.
• C. Ban electronic signatures.
• D. Automatic approval of changes without records.

Answer: (B)

One of the main ideas here is that FDA’s 21 CFR Part 11 sets requirements for how electronic records and electronic signatures must be controlled to be trustworthy and legally defensible. In CBM T6 electronic records and signatures, Part 11 focuses on the safeguards built into the systems that handle those records.

Specifically, you need system validation to prove the electronic platforms perform as intended and consistently produce accurate results. Audit trails are required to document who did what and when, creating a traceable history of changes. Access controls restrict system use to authorized personnel, preventing unauthorized access or edits. Data integrity controls protect the information from loss, alteration, or corruption, ensuring records remain complete and reliable over time. Together, these elements ensure electronic records are trustworthy and equivalent to their paper counterparts, with signatures that are properly linked to the records.

This isn’t about archiving only physical records, it doesn’t ban electronic signatures, and it doesn’t permit automatic changes without keeping records. The focus is on building and enforcing controls that preserve the integrity and accountability of electronic records and signatures.